{"id":198027,"date":"2024-10-19T12:36:27","date_gmt":"2024-10-19T12:36:27","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir80001-2-6-2014\/"},"modified":"2024-10-25T05:09:41","modified_gmt":"2024-10-25T05:09:41","slug":"aami-tir80001-2-6-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir80001-2-6-2014\/","title":{"rendered":"AAMI TIR80001 2 6 2014"},"content":{"rendered":"

Provides guidance for stakeholders on implementing RESPONSIBILITY AGREEMENTS to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a MEDICAL DEVICE into an IT-NETWORK in order to support compliance to ANSI\/AAMI\/IEC 80001-1. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the complete lifecycle of the resulting MEDICAL IT-NETWORK<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI\/ISO TIR80001-2-6:2014, Application of risk management for IT networks incorporating medical \u2014 Application guidance \u2014Part 2-6: Guidance for responsibility agreements <\/td>\n<\/tr>\n
3<\/td>\nCover page <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report
ANSI Registration <\/td>\n<\/tr>\n
6<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of AAMI adoption of ISO TR 80001-2-6 Ed.1 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
1.1 Purpose
1.2 Prerequisites
2 Normative References
3 Terms and Definitions <\/td>\n<\/tr>\n
16<\/td>\n4 Key aspects for responsibility agreements
4.1 Reasons and rationale
4.2 Participants
4.3 Proposed types of responsibility agreements
4.4 Communication control
4.4.1 Bilateral versus multilateral responsibility agreements
4.4.2 Non-disclosure agreements <\/td>\n<\/tr>\n
17<\/td>\n4.4.3 Update of information and documentation
4.5 Responsibility for establishing
4.6 Methods for determination and of responsibilities
4.7 Life cycle considerations
5 Elements of a responsibility agreement <\/td>\n<\/tr>\n
21<\/td>\nAnnex A: RACI chart <\/td>\n<\/tr>\n
22<\/td>\nAnnex B: Typical documents <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/IEC TIR80001-2-6:2014 – Application of risk management for IT-networks incorporating medical-Application guidance-Part 2-6: Guidance for responsibility agreements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2014<\/td>\n25<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198033,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198027","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198027","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198033"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198027"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198027"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198027"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}